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U.S. Department of Health and Human Services

Class 2 Device Recall MAGNETOM Aera/Skyra

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  Class 2 Device Recall MAGNETOM Aera/Skyra see related information
Date Initiated by Firm June 20, 2011
Date Posted August 10, 2011
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-2979-2011
Recall Event ID 59170
510(K)Number K101347  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging
Code Information Model numbers 10432914 and 10432915
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Meredith Adams
610-219-6300
Manufacturer Reason
for Recall		 Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, making servicing necessary.The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 20, 2011 to all affected customers. The letter describes the product, problem, and actions that will be taken. The letter informs customers that an inspection of the gradient cable connections and an emergency shutdown mechanism will be installed by a field service representative during a visit to all affected locations.
Quantity in Commerce 26
Distribution Nationwide Distribution-USA (nationwide) including the states of AK, FL, GA, IL, MA, MI, MN, MT, NC, NJ, NY, OH, TX, UT, VA, WA, and WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.
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